RPT-Pacific trade deal adds to U.S. price quandary for biotech drugs

NEW YORK/ATLANTA Oct 5 (Reuters) - The Pacific trade deal
agreed on Monday, which grants biotechnology drug producers less
protection than offered by the United States, could put more
downward pressures on the costly drugs' pricing in the
industry's most lucrative market.

The United States and 11 trading partners, including Mexico,
Japan, Canada and Australia, wrapped up five years of talks
after securing a compromise on protection for biotech drugs that
would help determine when less expensive versions known as
biosimilars can enter the market. [ID: nL3N1252R6]

The terms of the Trans-Pacific Partnership give drugmakers
at least five and potentially up to eight years of protection of
data needed to produce biosimilar medicines. Countries can sign
on for a minimum of five years of data exclusivity that with
added time for regulatory processes, would in effect provide a
"comparable outcome" to an eight-year time frame.

The agreement falls far short of the 12 years of data
protection enforced in the United States and which U.S. lobby
groups representing biotech and pharmaceutical companies from
Amgen Inc to Pfizer Inc sought to extend to
other nations.

The United States could still maintain 12 years in its own
market, since the trade deal language only sets minimum
standards.

Over time, however, the longer protection period compared
with its trading partners could come under pressure at home,
where anger over rising costs of medicines is growing among
doctors, patients and some lawmakers.

"If you see too much of a price discrepancy (between the
United States and trade partners), at some point you're going to
see a push back," said Steve Brozak, president of WBB Securities
which focuses on smaller biotechs.
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